PCR screening for dangerous fungal infections in leukemia patients
Mucorales PCR Screening in At-risk Hematology Patients
NA · Universitaire Ziekenhuizen KU Leuven · NCT05925660
This study is testing a new blood test to see if it can help find dangerous fungal infections earlier in leukemia patients who are getting chemotherapy.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Universitaire Ziekenhuizen KU Leuven (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Leuven, Vlaams-Brabant) |
| Trial ID | NCT05925660 on ClinicalTrials.gov |
What this trial studies
This clinical trial focuses on patients with leukemia who are undergoing intensive chemotherapy and may require stem cell transplantation, making them highly susceptible to invasive fungal infections like mucormycosis. The study aims to utilize a newly developed PCR test to detect Mucorales DNA in the blood, allowing for earlier diagnosis and intervention. By identifying the infection at an early stage, the trial seeks to improve survival rates, as timely treatment is critical for this rapidly progressing disease. The intervention involves the use of the MucorGenius PCR test developed by PathoNostics.
Who should consider this trial
Good fit: Ideal candidates include patients starting chemotherapy for acute myeloid leukemia or myelodysplastic syndrome, or those preparing for their first allogeneic hematopoietic cell transplantation with expected prolonged neutropenia.
Not a fit: Patients who are not undergoing chemotherapy or stem cell transplantation, or those with a stable immune system, may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce mortality rates associated with invasive mucormycosis in at-risk leukemia patients.
How similar studies have performed: Other studies have shown promise in using PCR for early detection of fungal infections, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Underlying disease: * Start of remission induction chemotherapy for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) that is newly diagnosed or in first relapse after hematological remission lasting for a minimum duration of 6 months; OR * Start of myeloablative conditioning regimen to prepare for a first allogeneic hematopoietic cell transplantation (HCT). * Expected prolonged neutropenia (ANC\< 0.5 x 109 /L for ≥ 7 days). * Planned hospital admission for the duration of the neutropenic phase.
Where this trial is running
Leuven, Vlaams-Brabant
- University Hospitals Leuven — Leuven, Vlaams-Brabant, Belgium (RECRUITING)
Study contacts
- Study coordinator: Robina Aerts, MD
- Email: robina.aerts@kuleuven.be
- Phone: +32 16 34 48 77
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Mucormycosis, Invasive Mycosis, Neutropenia, Leukemia, Stem Cell Transplant Complications, Invasive Mucormycosis